FDA Inspection
Big Rehab Corp.Big Rehab Corp. – FDA Inspection, Mar 1, 2011
Record Details
This FDA Inspection record concerns Big Rehab Corp., with an inspection on March 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Big Rehab Corp.
- Inspection Date
- March 1, 2011
- Product Type
- Devices
View Company Profile
ID · e1b00812-548b-4be6-8f44-45eba205c744
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712874
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Big Rehab Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Big Rehab Corp.
- FDA Inspection 949833 - 2015-11-13
- FDA Inspection 763363 - 2012-01-13
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